HIGH

Trifecta Pharmaceuticals Recalls Zinc Oxide Ointment Due to cGMP Deviations

Trifecta Pharmaceuticals recalled 33,000 containers of Globe Zinc Oxide Ointment on October 31, 2025, due to cGMP deviations. Consumers should stop using the product immediately to avoid potential risks. Healthcare providers are advised to contact the company for further guidance.

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brands
ZINC OXIDE 20%, Trifecta Pharmaceuticals USA
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

cGMP deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recalled product is Globe Zinc Oxide Ointment USP, containing 20% zinc oxide, in 2 oz containers. Lot numbers include A502404 and A502405, with an expiration date of February 27, 2025, and AS02502, expiring February 28, 2025. The ointment was distributed nationwide in the USA.

The Hazard

The recall stems from deviations in current Good Manufacturing Practices (cGMP), which can compromise product quality and safety. Such deviations may lead to contamination or ineffective product formulation.

Reported Incidents

No specific injuries or incidents have been reported related to this recall. The nature of the hazard reflects potential risks rather than reported adverse events.

What to Do

Consumers should stop using the recalled ointment immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance.

Contact Information

For further details, consumers can visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0212-2026.

Key Facts

  • 33,000 containers recalled
  • cGMP deviations identified
  • Stop using the product immediately
  • Contact healthcare provider for guidance

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot #: A502404
Exp. Date 2/27
A502405
Exp. Date 2/27
AS02502
+1 more
UPC Codes
69396-086
69396-086-02
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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